Device Classification Name |
Hearing Aid, Air-Conduction, Prescription
|
510(k) Number |
K964816 |
Device Name |
AUDINA 153 BEHIND THE EAR AND AUDINA 158 BEHIND THE EAR |
Applicant |
AUDINA HEARING INSTRUMENT |
150 EAST WILDMERE ST. |
LONGWOOD,
FL
32750
|
|
Applicant Contact |
FRANK J ROBILOTTA |
Correspondent |
AUDINA HEARING INSTRUMENT |
150 EAST WILDMERE ST. |
LONGWOOD,
FL
32750
|
|
Correspondent Contact |
FRANK J ROBILOTTA |
Regulation Number | 874.3300
|
Classification Product Code |
|
Date Received | 11/29/1996 |
Decision Date | 01/17/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|